BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221212 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10325
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED NO RELATED ISSUES OR ABNORMAL PUMP BEHAVIOR. DATA RELEVANT TO THE COMPLAINT WAS OVERWRITTEN DUE TO EXTENDED CONTINUED PUMP USE. THE TOTAL DAILY DOSE HISTORY WAS APPROPRIATE FOR THE USER PROGRAMMED DELIVERIES. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP PASSED A DELIVERY ACCURACY TEST. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE REPORTER (A HEALTH CARE PROFESSIONAL) CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE REPORTER WAS UNABLE TO PROVIDE THE BLOOD GLUCOSE READINGS OR INFORMATION ON THE PATIENT¿S TREATMENT. THE REPORTER STATED THAT PATIENT¿S PHYSICIAN REQUESTED THAT THE PUMP BE REVIEWED TO BE SURE IT IS FUNCTIONING PROPERLY. THE REPORTER STATED THAT THE PUMP WAS DOWNLOADED AND THERE WERE NO NOTED ISSUES WITH THE INFORMATION FROM THE DOWNLOAD. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ASSOCIATED WITH A REQUEST TO REVIEW THE PUMP TO ENSURE PUMP FUNCTION IMPLYING A SUSPECTED PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320127 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L